The following data is part of a premarket notification filed by Lukens Corp. with the FDA for Sixalyzer.
| Device ID | K880230 |
| 510k Number | K880230 |
| Device Name: | SIXALYZER |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | LUKENS CORP. AVE. PARQUE LIRA #79 COLONIA SAN MIGUEL CHAPULTEPEC Republica De Mexico 11850, TX 75261 |
| Contact | Lutz Kauffmann |
| Correspondent | Lutz Kauffmann LUKENS CORP. AVE. PARQUE LIRA #79 COLONIA SAN MIGUEL CHAPULTEPEC Republica De Mexico 11850, TX 75261 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-20 |
| Decision Date | 1988-03-16 |